Albumin replacement to improve oxygen delivery in sepsis patients
Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
This trial will try giving albumin to adults with sepsis in the ICU to see if it improves how much oxygen their blood delivers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsun University Academic / other |
| Locations | 1 site (Samsun, Ilkadım) |
| Trial ID | NCT06556914 on ClinicalTrials.gov |
What this trial studies
This is an observational study of adult sepsis patients treated in an ICU who develop low blood albumin after large-volume crystalloid resuscitation. Patients meeting the cutoff for hypoalbuminemia who have received ≥4 L/day of crystalloids will receive 20% albumin 100 mL once daily for three days according to the protocol, while routine sepsis care (antibiotics, fluids, vasopressors, source control) follows international guidelines. Investigators will record demographics, sepsis cause, comorbidities, SOFA and APACHE II scores, hemodynamics, transthoracic echo measures, blood gases, labs, and daily fluid balance to compare oxygen delivery and related parameters before and after albumin replacement. The analysis will describe changes in echo and blood-gas–derived measures of oxygen delivery associated with albumin administration in this ICU population.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU with sepsis who develop hypoalbuminemia (plasma albumin <2.5 g/dL) after receiving ≥4 L/day of crystalloid and who receive albumin replacement are the intended participants.
Not a fit: Patients without low albumin, those whose shock is hypovolemic, cardiogenic, or obstructive, pregnant people, or patients who die within 24 hours of ICU admission are unlikely to benefit from this intervention in this protocol.
Why it matters
Potential benefit: If helpful, albumin replacement could increase oxygen delivery and improve organ perfusion in septic ICU patients with low albumin.
How similar studies have performed: Use of albumin in sepsis has been studied for fluid balance and mortality outcomes, but direct study of its effect on oxygen delivery appears novel and not previously reported.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Followed up with a diagnosis of sepsis, * over 18 years old * Patients who were diagnosed with hypo-albuminemia after more than 4L/day fluid resuscitation and underwent albumin replacement Exclusion Criteria: * Consent is not given by the patient or his/her guardian, * The initial cause of shock was hypovolemic, cardiogenic or obstructive shock. * Pregnancy or suspected pregnancy * Peripheral limb or severe organ ischemia with peripheral artery disease * Cardiac functions cannot be evaluated optimally by transthoracic echocardiography * Patients who died within the first 24 hours after intensive care admission
Where this trial is running
Samsun, Ilkadım
- Samsun University — Samsun, Ilkadım, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: gamze MD ertaş, specialist — Samsun University
- Study coordinator: gamze MD ertaş, specialist
- Email: gamzeertas555@gmail.com
- Phone: 5056587914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.